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ISPE News, Regulatory News, and Student News
- Dutch Medicines Evaluation Board Gets New Deputy Director ()
- US FDA Publishes "Guidance Agenda - New & Revised Draft - Guidances CDER is Planning to Publish During Calendar Year 2012" ()
- Shinichi Osada, Former ISPE Board Member and ISPE Japan Leader Passes Away (May 17, 2013)
- PMMI and ISPE Partner to Launch Pharma EXPO (May 13, 2013)
- Overview of Changes to the Estonian Medicinal Products Act (May 7, 2013)
- Pharma Expo Announcement (May 6, 2013)
- Details on European Medicines Agency reorganisation (May 3, 2013)
- US FDA’s Collaboration with Chinese Partners Gets Stronger Each Year (May 3, 2013)
- US FDA Commissioner addresses using a public health approach to regulatory processes (May 1, 2013)
- EMA releases Guideline on Similar Biological Medicinal Products (April 26, 2013)
- US Senate Committee releases Draft Proposal on Pharmaceutical Compounding (April 26, 2013)
- Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. (April 24, 2013)
- ISPE invites Members to comment on EMA draft Guideline on Exposure Limits in Shared Facilities (April 19, 2013)
- CFDA Commissioner Zhang Yong meets the delegation of Swedish Ministry of Health and Social Affairs (April 16, 2013)
- Second ISPE-FDA Event Attracts Top Names, Features Release of Drug Shortage Survey Results (April 16, 2013)
- European Medicines Agency publishes 2012 annual report (April 16, 2013)
- EC introduces Quality Risk Management into revised Guideline on Good Distribution; ISPE helps Members prepare (April 15, 2013)
- Medicines and Healthcare Products Regulatory Agency launches its 2013-2018 corporate plan (April 11, 2013)
- US FDA publishes budget request for fiscal year 2014 (April 10, 2013)
- Japanese MHLW joins Japan’s first Public-Private Partnership to facilitate the R&D of new health technologies for the developing world (April 8, 2013)
- China obtains ISO/TC150/SC7 voting rights (April 8, 2013)
- ISPE invites Members to comment on two EMA draft Guidelines: GDP for API and Risk Assessment for Excipients (April 5, 2013)
- ISPEAK, April 2013: Midwest Chapter News (April 4, 2013)
- ISPE Releases New Guidance for Booklet Labels in Global Clinical Trials (April 3, 2013)
- Chinese SFDA adopts newly revised Good Supply Practice for Pharmaceutical Products (March 21, 2013)
Last Update: 15 June 2012
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